2009 North American Product Innovation of the Year Award
The 2009 Frost & Sullivan U.S. Biopharmaceutical Market Product Innovation of the Year Award is presented to Neotropix, Inc. This Award is in recognition of the company's innovative virotherapy NTX-010, an oncolytic virus being developed to treat small cell lung cancer and other neuroendocrine cancers. This state-of-the-art product provides a unique solution to the treatment of various forms of cancer by using a naturally occurring RNA virus that infects and kills cancer cells. NTX-010 offers benefits including convenient once-only dosing and an attractive side effect profile. In addition it has the potential to address unmet needs in the treatment of adults with Small Cell Cancer and Carcinoid Cancer as well as treating children with Neuroblastoma, Wilms' Tumor, Retinoblastoma, Ewing's Sarcoma, Rhabdoid Tumor, Alveolar Rhabdomyosarcoma, and Glioblastoma.
Biopharmaceuticals are a class of medications that are created using biotechnology. They are based on living sources and may be comprised of living cells, tissues, sugars, proteins, or nucleic acids. They are manufactured using highly technical manufacturing processes where living cells are modified to produce the biopharmaceutical drug. Over 150 biopharmaceuticals have been approved in the U.S.
Virotherapies are a novel class of biopharmaceuticals that use viruses as treatments for diseases. One type of virotherapy is natural oncolytic viruses, which are viruses that are able to infect and kill cancer cells without harming the surrounding normal cells. Because the virus does not harm normal cells it has only minor flu-like symptoms that last a day or two as a side effect. This compares very favorably to that of most cancer drugs that have numerous and profound side effects making patients very sick from the treatment.
NTX-010 is a virotherapy that is a naturally occurring, replication-competent, single-stranded RNA virus that infects and kills cancer cells. NTX-010 is a member of a new genus called Senecavirus in the Picornaviridae viral family. The drug is non-toxic to normal human cells, and has been determined by the USDA to be non-pathogenic. This virus, through a receptor mediated process, selectively targets neuroendocrine tumor cells that express at least one of the following three biomarkers: synaptophysin, CD56, and chromogranin A.
NTX-010 extends several advantages over other biopharmaceuticals and cancer therapies. Specifically it addresses unmet needs in the treatment of neuroendocrine cancers, it has an attractive side effect profile, and a convenient once-only dosing.
Chart 1.1 presents advantageous features of NTX-010.
Addresses Unmet Needs
NTX-010 is being developed to treat neuroendocrine cancers, including Small Cell Lung Cancer and carcinoids, both of whose treatments are associated with high levels of unmet medical needs. Small Cell Lung Cancer (SCLC) is highly aggressive and has very low survival rates. Current treatments are limited to surgery, chemotherapy, and radiation. All of these treatment options are associated with low success rates and for all patients, this disease is incurable. As such, more effective treatment options are highly sought after. Carcinoid cancer grows at a slower rate then small cell lung cancer but there are no anti-tumor treatments approved. Carcinoid cancer is also incurable.
Currently the only FDA approved first-line chemotherapy regimen for SCLC is a combination of cisplatin and etoposide, which has a low response rate with an estimated 20 to 25 percent of patients not responding to this treatment. In contrast, in animal models NTX-010 was shown to have a high therapeutic index and strong anti-tumor activity.
Preliminary results from Phase I/II open label clinical trial which included both SCLC and Carcinoid cancer patients found that a majority of patients responded to treatment with NTX-010, with one patient exhibiting a 50 percent reduction in tumor size as measured by a PET scans.
Convenient Dosing and Attractive Side Effect Profile
To treat Small Cell Lung Cancer, the frequency of dosing for chemotherapy varies, but is usually given every day for three days with the cycle repeated every 21 days. The combination of cisplatin and etoposide is administered through an IV infusion, which can be inconvenient for the patient. Comparatively, NTX-010 requires only one systemic dose because it is replication competent. This means that NTX-010 can replicate itself and expand within the tumor allowing it to make thousands of copies of itself from one virus particle. The convenience of once-only dosing may make it easier for patients to comply with their cancer therapy as well as improve the quality of life.
The combination of cisplatin and etoposide is associated with a high amount of adverse side effects including kidney damage, neurotoxicity, gastrointestinal problems, hypotension, myelosuppression, and hair loss. Furthermore, this form of treatment is highly toxic and has a 1 to 5 percent mortality rate. In contrast, NTX-010 has not been found to have any drug related serious side effects. The highly selective and targeted nature of the product kills only the cancer cells, leaving the healthy cells undamaged. In addition, NTX-010 appears to have no dose limiting toxicities.
Neotropix's NTX-010 offers an innovative approach to the treatment of Small Cell Lung Cancer and neuroendocrine cancers. NTX-010 provides important treatment benefits over traditional cancer medications, such as once-only dosing and an attractive side effect profile. Furthermore, preliminary results from clinical trials have been positive and highlight NTX-010's potential to be an effective treatment that addresses unmet needs for hard to treat cancers. As such, in recognition of the company's success in the development of the novel biopharmaceutical NTX-010, Frost & Sullivan is proud to present Neotropix, Inc. with the 2009 Product Innovation of the Year Award in the U.S. Biopharmaceuticals Market.
The Frost & Sullivan Award for Product Innovation of the Year is presented each year to the company that has demonstrated excellence in new products and technologies within its industry. The recipient company has shown innovation by launching a broad line of emerging products and technologies.
To choose the recipient of this Award, the analyst team tracks all new product launches, R&D spending, products in development, and new product features and modifications. This is accomplished through interviews with the market participants and extensive secondary and technology research. All new product launches and new products in development in each company are compared and evaluated based on degree of innovation and customer satisfaction. Companies are then ranked by number of new product launches and new products in development.
In addition to the methodology described above, there are specific criteria used to determine final competitor rankings in this industry. The recipient of this Award has excelled based on one or more of the following criteria:
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